EMA — authorised 21 August 2020
- Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
- Status: approved
🇪🇺 Kalydeco in European Union
EMA authorised Kalydeco on 21 August 2020
Marketing authorisation
Kalydeco in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in European Union
Frequently asked questions
Is Kalydeco approved in European Union?
Yes. EMA authorised it on 21 August 2020.
Who is the marketing authorisation holder for Kalydeco in European Union?
Vertex Pharmaceuticals (Ireland) Limited holds the EU marketing authorisation.